Exchanger surgical access port and methods of use

ABSTRACT

A surgical instrument access port assembly and method of use, the surgical instrument access port a surgical instrument has a needle lumen and a surgical access port. The needle lumen extends in a longitudinal direction and includes a needle tip at a distal end, and a body portion at a proximal end, the body portion having at least one recess or finger. The surgical access port has a cannula defining a hollow cannula shaft, and a tapered hub attached to a proximal end of the cannula. The tapered hub includes at least one inner ring configured to abut against the at least one recess or finger while the surgical instrument is inserted into the cannula of the surgical access port.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a Continuation of U.S. patent applicationSer. No. 14/798,987, filed Jul. 14, 2015, which claims the prioritybenefit of U.S. Provisional Patent Application No. 62/024,999, filedJul. 15, 2014, the entire disclosures of which are incorporated byreference in their entirety.

TECHNICAL FIELD

The present disclosure relates to surgical instruments and methods oftheir use, and more particularly to minimally invasive surgicalinstruments, an exchanger surgical access port, and methods of using anexchanger surgical access port so that multiple instruments can be usedtherein.

Examples of minimally invasive surgical assemblies and related equipmentare described in U.S. Pat. No. 7,766,937 to Ravikumar, U.S. Pat. No.8,230,863 to Ravikumar et al., U.S. Pat. No. 8,313,507 to Ravikumar,U.S. Pat. No. 8,133,255 to Ravikumar et al., U.S. patent applicationSer. No. 11/685,522 to Ravikumar et al. (published as U.S. Patent Pub.No. 2007/0250112), U.S. patent application Ser. No. 12/503,035 toRavikumar (published as U.S. Patent Pub. No. 2010/0016884), U.S. patentapplication Ser. No. 11/610,746 to Ravikumar et al. (published as U.S.Patent Pub. No. 2007/0282170), and U.S. patent application Ser. No.12/689,352 to Ravikumar et al. (published as U.S. Patent Pub. No.2010/0292724), all of which are incorporated by reference herein intheir entireties.

DESCRIPTION OF RELATED ART

Over the last two decades, minimally invasive surgery has become thestandard for many types of surgeries which were previously accomplishedthrough open surgery. Minimally invasive surgery generally involvesintroducing an optical element (e.g., laparoscopic or endoscope) througha surgical or natural port in the body, advancing one or more surgicalinstruments through additional ports or through the endoscope,conducting the surgery with the surgical instruments, and withdrawingthe instruments and scope from the body. In laparoscopic surgery(broadly defined herein to be any surgery where a port is made via asurgical incision, including but not limited to abdominal laparoscopy,arthroscopy, spinal laparoscopy, etc.), a port for a scope is typicallymade using a surgical trocar assembly.

The trocar assembly often includes a port, a sharp pointed element(trocar) extending through and beyond the distal end of the port, and atleast in the case of abdominal laparoscopy, a sealing valve on theproximal portion of the port. The term trocar typically includes acombination of cooperating elements such as a cannula, a seal housing,and an obturator. First the obturator cuts or pierces the body wall sothat the cannula may be inserted. The cannula defines a pathway througha body wall through which the surgical instruments are inserted.Finally, the seal housing provides an isolation of the cannula so thatif insufflation is employed the body region remains distended andsealed. All three components are usually fitted together and used as asingle unit for passage by one or more surgical instruments through thebody wall and into a body cavity.

Laparoscopic surgery typically begins as the surgeon inserts a largebore needle through a body wall and into the internal region associatedwith the body wall. Next, an inflation or insufflation gas is pumpedinto the internal region until it is properly distended. The body walland internal region are now ready for insertion of trocars.

Typically, a small incision is made in the skin at a desired location inthe patient. The incision may be made via a scalpel or other sharpinstrument. The trocar assembly, with the trocar extending out of theport, is then forced through the incision via the obturator which cutsor pierces the body wall, thereby widening the incision and permittingthe port to extend through the incision, past any fascia, and into thebody (cavity). The trocar is then withdrawn, leaving the port in place.

If not already distended, an insufflation element may be attached to thetrocar port in order to insufflate the surgical site. An optical elementmay then be introduced through the trocar port. Additional ports arethen typically made so that additional laparoscopic instruments may beintroduced into the body.

Trocar assemblies are manufactured in different sizes. Typical trocarport sizes include diameters of about 5 mm, 10 mm, and 12 mm, which aresized to permit variously sized laparoscopic instruments to beintroduced therethrough including, e.g., graspers, dissectors, staplers,scissors, suction/irrigators, clamps, forceps, biopsy forceps, etc.While 5 mm diameter trocar ports are relatively small, in somecircumstances where internal working space is limited (e.g., children),it is difficult to place multiple 5 mm diameter ports in the limitedarea of the patient. In addition, 5 mm diameter trocar ports tend tolimit movement of instruments inside the abdominal cavity to a greatextent. Such a conventional 5 mm diameter trocar has a sealing valve andsealing mechanism and therefore the opening for the surgical instrumentis limited.

Further, while laparoscopic surgery has reduced the trauma associatedwith various surgical procedures and has concomitantly reduced recoverytime from these surgeries, there always remains a desire in the art tofurther reduce the trauma to the patient.

One area of trauma associated with laparoscopic surgery identified bythe inventors hereof as being susceptible of reduction are the scarswhich result from the trocar ports used. In many laparoscopic surgeries,three or more trocar incisions are made. For example, in laparoscopichernia repair surgery, four trocar incisions are typically made, withone incision for insufflating the abdomen and inserting the opticaldevice, two incisions for trocar ports for inserting grasperstherethrough, and a fourth port for passing a stapler therethrough.Those skilled in the art and those who have undergone surgicalprocedures understand that even the 5 mm diameter trocar ports leaveholes which must be stitched and which result in scars. Scar tissue mayaffect the internal portion of the fascia as well as the cosmeticappearance of the skin, which may be detrimental for the patient or evena surgeon if that area of the skin is subject to a later incision ormedical procedure.

A second area of trauma associated with laparoscopic surgery relates totrauma resulting from the manipulation (e.g., angling) of the trocarports required in order to conduct the surgery due to inexact placement.Angling of the port can cause tearing at the incision periphery. Suchtearing can lead to extensive scar tissue and in general an extension ofthe incision area. Again, conventional 5 mm diameter trocars including avalve and sealing mechanism are hard to angle in regard to the openingfor the surgical instrument. Thus a need exists for a surgical accessport which is not subject to tearing fascia at the point of incisioninto the patient.

A further problem with surgical instruments including a needle tip isinadvertent needle penetration in tissue and resulting scarring or evenmore serious complications during the surgery if other tissue is nickedor penetrated unintentionally. Indeed, placing a sharp instrument suchas an inflation needle or trocar obturator through a body wall and intoan associated internal region comes with considerable risk. The humanabdomen, for example, is a tightly packed region that is filled withdelicate structures and organs. There is no open space between theabdominal wall and those structures or organs until inflation gas isinserted and a pneumoperitoneum is established. Great care must be takenwhen placing inflation needles so as to avoid penetration of intestine,bowel or other structures. Even after insufflation is established, thereis a risk of injury during placement of additional sharp instrumentsthrough the distended body wall. The body wall is comprised of skin,muscle, fat, and a thin membrane. The wall may be thick, muscular andtough or it may be lean and soft. As such, placement of a sharpobturator through the body wall requires great skill and knowledge ofwhat lies within the internal region. The force required to insert asharp trocar through a body wall can exceed forty pounds in some cases.This applied force easily overcomes the pneumoperitoneum and forces thebody wall down and against delicate structures where there is the dangerof piercing or cutting those structures.

To combat the need for such force of insertion of a typical trocar, somesurgeons have also used a technique referred to as a “cut down”procedure where successive small incisions are made until the body wallis cut through, at which time a blunt trocar or a trocar obturator isinserted with a certain level of force. This process may incur lessforce but it is time-consuming and may leave a deeper and larger scar.As such, a need exists for a surgical access port which is easier toinsert into a body wall.

A further need exists for a surgical access port which is secured to theouter fascia of the patient. Certain known securing means includepinching of the skin which can lead to scarring and other complications,while other securing means include various adhesive measures. A lessobtrusive (less scarring) yet secure means is needed so that the trocardoes not move when in use.

There continues to be a need in the art for a surgical access port whichreduces trauma to the patient, reduces complications to the patient,does not lead to extension of the incision area, does not lead toincreased scar tissue generation, is easy to make and use, and improvessafety while reducing costs to health care providers and patients andreducing the surgical time for a procedure which in turn may reducecosts and complications. The inventive surgical access port includes atrocar having a cannula with a diameter of about 1 mm to about 3 mmincluding a removable obturator having a diameter of about 1 mm to about3 mm which is capable of insertion into a patient's skin and body wall.

While conventional trocars including an obturator are known, theconventional art includes a cannula with a diameter exceeding about 5mm. Thus there exists a need for a surgical access port which includes asmaller diameter cannula.

Further, the conventional trocars are inserted manually through forceand thus a need exists where a surgical access port may be inserted viaa surgical instrument itself having a needle for insertion into thepatient's skin and body wall. These and other needs are met by theinventive surgical access port and method for insertion and method ofuse.

Further, conventional trocars include a valve and sealing means so as toprevent gas leakage during insufflation. A need exists for a morestreamlined trocar without an additional valve or sealing means whilestill maintaining sufficient insufflation during surgery. A need existsfor a surgical access port without a valve or sealing means while stillmaintaining an acceptable gas pressure level or minimal leakage.

Other advantages of the present invention will become apparent from thefollowing description and appended claims.

SUMMARY

According to one aspect, the disclosure describes an access portassembly. The access port assembly comprises an obturator having alongitudinally extending obturator shaft including a sharp tip disposedat a distal end of the obturator shaft and a handle disposed at aproximal end of the obturator shaft, the handle including at least onefinger extending spaced from the handle. The access port assemblyfurther comprises a surgical access port having a cannula defining ahollow cannula shaft, and a tapered hub attached to a proximal end ofthe cannula. The tapered hub includes at least one inner ring configuredto abut against the at least one finger while the obturator is insertedwithin the cannula of the surgical access port.

According to one aspect, the disclosure describes a surgical instrumentaccess port assembly. The surgical instrument access port assemblycomprises a surgical instrument having a needle lumen extending in alongitudinal direction including a needle tip at a distal end, and abody portion at a proximal end, the body portion including at least onerecess or finger. The surgical instrument access port assembly furthercomprises a surgical access port having a cannula defining a hollowcannula shaft, and a tapered hub attached to a proximal end of thecannula. The tapered hub includes at least one inner ring configured toabut against the at least one recess or finger while the surgicalinstrument is inserted into the cannula of the surgical access port.

According to one aspect, the disclosure describes a method of using asurgical instrument access port assembly comprising a surgicalinstrument having a needle lumen extending in a longitudinal directionincluding a needle tip at a distal end, and a body portion at a proximalend, the body portion including at least one recess or finger, andincluding a surgical access port having a cannula defining a hollowcannula shaft, and a tapered hub attached to a proximal end of thecannula, the tapered hub including at least one inner ring configured toabut against the at least one recess or finger while the surgicalinstrument is inserted into the cannula of the surgical access port. Themethod comprises piercing a hole in a body wall with the needle tip ofthe needle lumen, inserting at least a portion of the needle lumenthrough the hole into a body cavity, advancing the surgical access portalong the needle lumen in a distal direction towards the hole, andinserting the cannula of the surgical access port through the hole intothe body cavity.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a side view of an exemplary surgical access port assemblyin accordance with aspects of the disclosure.

FIG. 2 shows a first perspective view of the exemplary surgical accessport assembly of FIG. 1 in accordance with aspects of the disclosure.

FIG. 3 shows a second perspective view of the exemplary surgical accessport assembly of FIG. 1 in accordance with aspects of the disclosure.

FIG. 4 shows a side perspective view of an exemplary surgical accessport in accordance with aspects of the disclosure.

FIG. 5 shows a top perspective view of the exemplary surgical accessport of FIG. 4 in accordance with aspects of the disclosure.

FIG. 6 shows a cross-sectional side view of the exemplary surgicalaccess port of FIG. 4 in accordance with aspects of the disclosure.

FIG. 7 shows an exploded view of an exemplary surgical access portassembly in accordance with aspects of the disclosure.

FIG. 8 shows a side view of an exemplary obturator in accordance withaspects of the disclosure.

FIG. 9 shows a cross-sectional side view of an exemplary obturator inaccordance with aspects of the disclosure.

FIG. 10 shows an exploded view of an exemplary surgical access portassembly in accordance with aspects of the disclosure.

FIG. 11 shows an exploded view of an exemplary locking mechanismassembly in accordance with aspects of the disclosure.

FIG. 12 shows a bottom view of an exemplary ball of the lockingmechanism of FIG. 11 in accordance with aspects of the disclosure.

FIG. 13 shows a perspective view of the exemplary ball of the lockingmechanism of FIG. 11 in accordance with aspects of the disclosure.

FIG. 14 shows a side view of an exemplary surgical access port includinga needle lumen in accordance with aspects of the disclosure.

FIG. 15 shows a partial cross-sectional view of the exemplary surgicalaccess port of FIG. 14 in accordance with aspects of the disclosure.

FIGS. 16-24 show methods of using an exemplary surgical access port inaccordance with aspects of the disclosure.

DETAILED DESCRIPTION

In accordance with aspects of the disclosure, a surgical access portassembly 100 may include a surgical access port with a cannula, a hub,and an obturator. In one aspect, the surgical access port may beconnected or usable with a laparoscopic instrument having an elongatedcannula such that the surgical access port is placed over the cannula ofthe laparoscopic instrument and thus does not require an obturator asthe laparoscopic surgical instrument. In one aspect, the laparoscopicinstrument may include a needle and the needle may pierce a patient'sskin and thereafter the surgical access port may be inserted into thesurgical site.

Now referring to the drawings, wherein like reference numerals refer tolike elements, FIG. 1 shows the surgical access port assembly 100, whichmay include a surgical access tube or a cannula 115 having a diameter ofabout 1 mm to about 5 mm thereby reducing trauma to the patient andeliminates the need for a larger incision point or for a series of smallincision cuts through the various layers of fascia. In one aspect, thediameter of the cannula 115 may be less than about 3 mm, such as between2.3 mm to about 2.96 mm. The incision point may be 5 mm or lessdepending on a diameter of the distal tip portion of the obturator orthe needle of the laparoscopic surgical instrument.

Referring now to FIGS. 1-3 , the surgical access port assembly 100 mayinclude a surgical access port 110, an obturator 200, and a lockingmechanism 300. In one aspect, the obturator 200 may be eliminated andthe surgical access port assembly 100 may be affixed over a cannula of asurgical instrument as will be described in further detail below withreference to FIGS. 16-25 .

As shown in FIGS. 1-6 , the surgical access port 110 may have anelongated cannula 115. A distal end 117 of the elongated cannula 115 maybe blunt or beveled. The elongated cannula 115 may define a hollowcannula shaft 116, through which surgical instruments or the obturator200 may be inserted and pass through when the surgical access port 110is in use. The elongated cannula 115 may include a proximal endconnected to a hub 120. The hub 120 may define an outer diameter whichexpands outwardly, relative to a central axis, in a proximal directionfrom the proximal end of the elongated cannula 115. The hub 120 mayinclude a portion 122 connected to the proximal end of the elongatedcannula 115, an outer ring portion 124 which may be used by a surgeonfor manual manipulation of the surgical access port 110, and a taperedopen end portion 126 of the hub 120 with a diameter exceeding that ofthe elongated cannula 115. The tapered open end portion 126 of the hub120 may be capable of housing the obturator 200, as well as providingaccess for surgical instruments and devices during surgery. The surgicalaccess port 110 may be made of various materials that may have rigidmaterial properties and may include metals or plastics. For example, thematerials may include stainless steel, liquid crystal polymer orpolycarbonate, glass-filled polycarbonate, or the like. The materialshould be compatible with the human fascia, body wall and any bodycavity into which the surgical access port 110 is inserted so as toprevent or reduce any allergic reaction by the patient upon insertion.Of course, other compatible materials are of course contemplated.

Additionally, the surgical access port 110 may be covered or coated onthe outside, and/or within the hollow cannula shaft 116, with aninsulating material (not shown) to prevent electrical current transferto the patient, for instance, upon inadvertent contact with anelectrical surgical apparatus such as a monopolar or bipolar surgicalinstrument. The insulating material may be a plastic shrink wrap or anyother insulating materials such as plastics, polymers, elastomers andthe like, and combinations thereof.

Turning to FIGS. 4-6 , the hub 120 of the surgical access port 110 mayhave an inner portion including at least one inner ring, shown in FIGS.5 and 6 as inner rings 118A, 118B and 118C. Each of the inner rings118A, 118B, 118C, may define a rib or groove on an inner surface of thehub 120. The inner rings 118A, 118B, 118C may be used as a securingmeans for attaching and securing the obturator 200 via fingers 230 tothe hub 120. In one aspect, the inner rings 118A, 118B, 118C may be usedto connect the surgical access port 110 to a surgical instrument ordevice over such instrument's cannula. In one aspect, at least one ofthe inner rings 118A, 118B, 118C may include an O-ring made with acompressible material so as to seal a portion of the surgical accessport 110 and deter leakage of gas during surgical insufflation. Forexample, the O-ring may be made of rubbers, foams, plastics, silicones,fluorocarbons, polymers, elastomers, nitriles and the like, includingcombinations thereof. In one aspect, the at least one inner ring 118A,118B, 118C including the O-ring may abut the fingers 230 of theobturator 200 when the obturator 200 is secured to the surgical accessport 110. Alternatively, the at least one inner ring 118A, 118B, 118Cincluding the O-ring may located downstream or upstream of the fingers230 of the obturator 200 when the obturator 200 is secured to thesurgical access port 110.

The surgical access port 110 may include a cap 150 (as shown in FIG. 7 )connected to the hub 120 via a cap tether 160 and a ring 170 secured tothe hub 120. In one aspect, once the surgical access port 110 has beeninserted into the patient's body during surgery, there may be instanceswhere a surgical instrument is not employed through the surgical accessport 110. The cap 150 may be mounted or attached to the tapered open endportion 126 of the hub 120 in order to seal the surgical access port110, thereby preventing gas leakage associated with surgicalinsufflation and/or to prevent contaminates from entering the bodycavity.

For instance, when one surgical instrument is removed from the surgicalaccess port 110 and before another surgical instrument can be insertedinto the surgical access port 110, the cap 150 may be secured to thetapered open end portion 126. As a further safety measure, the cap 150may also be mounted or attached to the tapered open end portion 126 ofthe hub 120, prior to the surgical access port 110 being used on apatient, to prevent contaminates from entering into the hollow cannulashaft 116. In one aspect, a tip 130 may be employed to engage the distalend 117 of the surgical access port 110 to also prevent contaminatesfrom entering into the hollow cannula shaft 116. Additionally, the tip130 may also be used as a cover for a sharp tip 250 of the obturator 200when the obturator 200 is not in use, thereby serving as a guard for thesharp tip 250 and preventing accidental needle tip trauma.

Turning to FIG. 7 , the obturator 200 may include an obturator shaft240, which may include a diameter that is less than or equal to adiameter of the hollow cannula shaft 116. The diameter of the obturatorshaft 240 may be less than about 3 mm, and may be in one aspect, between2.3 mm to about 2.96 mm. As shown in FIGS. 7-9 , the sharp tip 250 maybe provided at the distal end 117 of the obturator shaft 240. The sharptip 250 may be conical in shape, blunt in shape, or may include a needleor blade (not shown) to assist in insertion of the surgical access port110 into a patient's fascia and through the body cavity wall. A handle220 may be disposed at a proximal end of the obturator shaft 240, andmay be used by a user for manual manipulation of the surgical accessport assembly 100. The handle 220 may include an end or handle 210 forgrasping by the user, and at least one finger 230 for securing theobturator 200 to at least one inner ring 118A, 118B, 118C of the hub120, or an inner surface of the hollow cannula shaft 116

As shown in FIGS. 8 and 9 , the finger 230 may connect to an inner ring118A by flexing and snapping into place, but may be moved by lightmanipulation of the handle 210 by the user so as to remove the obturator200 once the surgical access port 110 is in place on the patient. Inuse, the obturator 200 may be directed to penetrate the patient's fasciaand a body wall to provide the surgical access port 110 and its cannula115 with access across the body wall and into a body cavity. Theobturator 200 may be made of various materials which are compatible withthe human fascia, body wall and any body cavity into which it isinserted so as to prevent or reduce any allergic reaction by the patientupon insertion. The obturator 200 may be made may be a rigid plastic,rubber, polymer, elastomer, metal, and the like, and combinationsthereof. Of course, other compatible materials are of coursecontemplated.

The surgical access port assembly 100 may further include a lockingmechanism 300 to secure the surgical access port 110 to an outer layerof fascia of the patient. FIGS. 10 and 11 illustrate exploded views ofthe locking mechanism 300. The locking mechanism 300 may include a lockbase 310 having an aperture 315 through which the cannula 115 of thesurgical access port 110 may be inserted through. The lock base 310 mayinclude at least one tab 312A, 312B, and preferably two tabs spacedapart from one another to provide a grip to the user and/or providelimits to a locking member 320. The lock base 310, including the tabs312A, 312B, form a part of the locking mechanism 300 that is secured tothe outer fascia layer of the patent such that the surgical access port110 remains in a set position relative to the patient when in use. Thelock base 310 may further include at least one screw thread or ramp 314which connectable with at least one snap or finger 324 of the lockingmember 320.

The locking member 320 may define an aperture 325 through which thecannula 115 of the surgical access port 110 is inserted. The lockingmember 320 may include at least two lock tabs 322A, 322B which mayextend radially from the locking member 320 and may be used as a grip bythe user, and/or to limit the rotational movement of the locking member320 relative to lock base 310. The locking mechanism 300 may be made ofvarious materials which are compatible with the human fascia so as toprevent or reduce any allergic reaction by the patient upon adhesionthereof. The locking mechanism 300 may be made may be a rigid plastic,rubber, polymer, elastomer, metal, and the like, and combinationsthereof. Of course, other compatible materials are of coursecontemplated.

The locking member 320 of the locking mechanism 300 may be rotatablyattached to the lock base 310. In one aspect, the locking mechanism 300may include a plurality of snaps or fingers 324, which may correspond toa number of screw threads 314 of the lock base 310. Each of theplurality of snaps may extend downwardly parallel to a central axis ofthe locking member 320. Each of the snaps or fingers 324 may furtherinclude a radially extending protrusion to engage with a groove of arespective screw thread or ramp 314. The snaps or fingers 324 may engagewith the screw threads or ramps 314, and the locking member 320 may berotated relative to the lock base 310. In one aspect, as the lockingmember 320 is rotated clockwise to a locked position, the snaps orfingers 324 may be guided by the grooves of the screw threads todisplace the locking member 320 axially towards the lock base 310.Conversely, as the locking member 320 is rotated counter-clockwise to anunlocked position. The snaps or fingers 324 may be guided by the groovesof the screw threads to displace the locking member 320 axially away thelock base 310. Additionally, the groove of the screw threads 314 maycooperate with a taper of the aperture 315 such that as the lockingmember 320 is threaded axially towards the lock base 310, the snaps orfingers 324 may apply a compressive force inwardly towards a center ofthe aperture 315, and may cause the aperture 315 is compress inwardly.Of course, it will be appreciated to one skilled in the art in view ofthis disclosure that the direction of the threading may be reversed suchthat a counter-clockwise rotation of the locking member 320 may be usedto place the locking mechanism 300 in the locked position, while aclockwise rotation of the locking member 320 may be used to place thelocking mechanism 300 in the unlocked position.

The locking mechanism 300 may further include a ball 330, shown indetail in FIGS. 12 and 13 , and may be disposed between the lock base310 and the locking member 320. The ball 330 may be housed between theapertures 315 and 325 of the lock base 310 and the locking member 320,respectively. The ball 330 may include an opening or aperture 335through which the cannula 115 of the surgical access port 110 may beinserted. The ball 330 may be made of a material which is compressible,such as plastic, polymers, elastomers, rubber or the like. The ball 330may also include at least one slit 336 which is compressible when thelocking mechanism 300 is in a locked position, as will be described infurther detail below. The slit 336 may enable the surgical access port110 to be moved at an angle within the apertures 315, 325, and 335. Inone aspect, when the locking mechanism 300 is in an unlocked position,the ball 330 may be rotated about 45° relative to a horizontal planedefined by the lock base 310 and 45° relative to a horizontal plane ofthe locking member 320. The locking mechanism 300 may then be placed ina locked position, whereby the locking member 320 compresses theaperture 315 inwardly, which may in turn cause the ball 330 to compressinwardly by displacing at least a surface of the ball 330 via the atleast one slit 336, thus securing a position of the ball 330 relative tothe lock base 310 and the locking member 320.

Once an angle of the surgical access port 110 is chosen or finalized,the locking mechanism 300 is actuated by rotating the lock tabs 322A,322B relative to the base tabs 312A, 312B. In one aspect, the user maysqueeze or pinch tabs 312A and 322A together using a thumb and indexfinger, for example, which may in turn squeeze and collapse the at leastone slit 336 of the ball 330. To unlock the locking mechanism 300 theuser may squeeze or pinch the opposite tabs, such as tabs 312B and 322Btogether, using a thumb and index finger, which may in turn release theat least one slit 336 of the ball 330.

The locking mechanism 300 may further be secured to the patient's skinand thus secure the surgical access port 110 when it is inserted intothe patient's fascia. An underside of the base 310 may be coated with anadhesive and the adhesive may be covered and protected by a paper liner340 prior to use. The paper liner 340 may include a tab 345 to assistthe user in gripping and removing the paper liner 340 from the base 310.In one aspect, the paper liner 340 may be perforated or may include aseparation line to assist in the removal of the paper liner 340 even ifone or more of the surgical access port 110, the obturator 200, and thesurgical instrument has been inserted through the locking mechanism 300.Once the paper liner 340 is removed, the adhesive is exposed such thatthe adhesive may be placed onto the fascia of the patient to therebysecure the locking mechanism 300 and surgical access port 110 to thepatient's fascia. Any known adhesive compatible to the fascia of apatient may be used. By securing the locking mechanism 300 to the fasciaof the patient, the surgical access port 110 may be secured without theneed for pinching or other securing means which may be harmful to thepatient. This benefit is of immediate notice and effect to the surgeonand to the patient's fascia.

As shown in FIGS. 10 and 11 , the lock base 310 may comprise of a baseplatform 316, having a flat bottom surface, on which an adhesive layerand a peelable protective paper liner 340 may be applied, a top surfacewhich defines at least two finger tabs 312A, 213B, and a central ring318 with an inner surface defining the aperture 315. The central ring318 may include a slightly tapered frustoconical inner surface forreceiving the ball 330 and may further include at least two or threeseparate outer screw threads or ramps on an outer surface which arerecessed into the central ring 318 and start at the top surface of thering 318 and descend as they extend clockwise about the ring 318 untilthey reach a top of the base platform 316, thereby forming small ledgesfor purposes explained hereinafter.

In one aspect, the ball 330 may be a hollow plastic ball provided withopposite circular openings sized to closely receive the cannula 115 ofthe surgical access port assembly 100, and a plurality of slits 336which extend about 120° from the opening in the direction of the axisdefined by openings. With the slits 336, the ball 330 may be compressedsuch that if a circumferential force is applied to the ball 330, thelobes 337 formed between the slits 336 will move toward each other. Thelocking member 320 may comprise a cap with at least two extending armsor tabs 322A, 322B. The cap 326 may have a top wall 327 with a centralopening 328 defining the aperture 325 through which the top portion ofthe ball 330 can extend. The cap 326 may also have a side wall withcut-outs which define engagement fingers or snaps or fingers 324. Theengagement fingers 324 may have bosses which are sized to ride in theramps of the central ring 318 of the lock base 310 and the inward facingbosses may be ramped or beveled.

With reference to FIGS. 10 and 11 , assembly of the locking mechanism300 will now be described. In one aspect, the ball 330 may be placedbetween the lock base 310 and the locking member 320 with the bosses 324a of the engagement fingers 324 being forced over the ledges and intoengagement with the ramps 314 of the lock base 310. In this position abottom of the side wall of the cap 326 of the locking member 320 isspaced relative to a top surface of the base platform 316 of the lockbase 310, and the ball 330 is free to rotate as guided by the ring 318and central opening 325. Thus, when the cannula 115 of the surgicalaccess port assembly 100 is inserted through the circular openings 335of the ball 330, the cannula 115 will have considerable freedom ofmovement, limited only by the size of the central opening 325 of thelocking member 320 and the frustoconical central opening 315 of the lockbase 310. In one aspect, the locking mechanism 300 may be provided afreedom of movement of at least 45° relative to the vertical in alldirections for the cannula 115 of the present disclosure, therebyresulting in a range of angles for insertion of the surgical access portassembly 100. However, when the locking member 320 is rotated clockwiserelative to the lock base 310 (typically by squeezing finger tabs 312A,322A together with a thumb and forefinger), the bosses 324 a ride downthe ramps 314 and pull the locking member 320 closer to the lock base310. Since the ball 330 cannot move downward in the ring 318, thecentral opening 315 provides a circumferential force to the ball 330(i.e., it compresses the ball), thereby forcing the lobes 337 inward,and applying friction to the cannula 115 of the surgical access portassembly 100, when installed. As a result, not only is the cannula 115locked in place relative to the ball 330, but the ball 330 is fixed inits rotational orientation relative to the locking mechanism 300. Theball 330 and cannula 115 may be released by rotating the locking member320 counterclockwise relative to the lock base 310 (typically bysqueezing the other finger tabs 312B, 322B together). The locking member320, however, cannot lift off the lock base 310 because the ledges actas stops.

FIGS. 14 and 15 show the surgical access port 110 connected to a needlelumen 400 having a lumen shaft 420 and an end effector such as a needle410, in accordance with an aspect of the present disclosure. The needlelumen 400 may be inserted into a reposable handgrip surgical instrumentor any other surgical instrument. The needle lumen 400 may be insertedinto an aperture of the surgical access port 110 via the open endtapered portion 126 of the hub 120 and through the hollow cannula shaft116 of the elongated cannula 115 (as shown in FIG. 6 ). The surgicalaccess port 110, including the locking mechanism 300 (as generally shownin FIG. 11 ), may thus be connected to the needle lumen 400 by frictionand light compression of the inner rings 118A, 118B, and 118C of the hub120. In one aspect, the needle lumen 400 may comprise a body portion 430defining a recessed portion 432. The body portion 430 may be insertedinto the tapered open end portion 126 such that the recessed portion 432extends beyond at least one of the inner rings 118A, and abuts againstthe inner ring 118A. In one aspect, a distal portion 434 of the bodyportion 430 may define a tapered outer surface corresponding with atapered inner surface of the hub 120, as shown in FIG. 15 .

The recessed portion 430 of the needle lumen 400 may be provided to abutat least one of the inner rings 118A, 118B, and 118C to thereby securethe needle lumen 400 to the hub 120. Additionally, or alternatively,fingers like the ones found on the obturator 200 may be provided tointeract with one or more of the inner rings 118A, 118B, and 118C of thehub 120. In use the needle 410 of the needle lumen 400 may be used topenetrate the patient's fascia, the surgical access port 110 may bemoved in an axial movement down the needle lumen 400 via manualmanipulation of the outer ring 124 and the surgical access port 110 maybe inserted into the patient's fascia and through the body wall.

In accordance with an aspect of the present disclosure, the surgicalaccess port 110 including the locking mechanism 300 may be connected toa lumen of a surgical instrument or device wherein the lumen has aneedle or other insertion means. The lumen of the surgical instrumentmay be inserted into the patient's fascia and the surgical access port110 may be slid down the length of the lumen and inserted into thepatient's fascia and the body wall. Generally, prior to the lumen of thesurgical instrument being inserted into the patient, the surgical accessport 110 may be attached to the lumen of a percutaneous instrument, orsingle needle lumen, by sliding the surgical access port 110 along alength of the lumen and connected to the instrument via the one or moreinner rings 118A, 118B, 118C of the surgical access port 110. After thesurgical instrument has been inserted into the patient, the surgicalaccess port 110 may then be advanced along the lumen, away from thepercutaneous instrument if in such embodiment, into the patient'sfascia, through the body wall and into a body cavity. The lumen of thesurgical instrument may then be removed while the surgical access port110 remains in the body cavity. In one aspect, the removed surgicalinstrument may be replaced with a different surgical instrument.

In one aspect, the surgical instrument may be a needlescopic instrumenthaving a lumen with a diameter of less than about 3 mm. In one aspect,the diameter of the lumen is between 2.3 mm to 2.96 mm, with the lumenincluding a needle and may include additional end-effectors such asjaws. The surgical access port 110 may be placed around the lumen of thesurgical instrument while the surgical instrument is outside of thepatient, but can be unsnapped from the surgical instrument, and insertedinto the patient's fascia, providing a guide for additional percutaneousinstruments to be inserted therein.

As shown in FIGS. 16 through 24 , exemplary methods of using thesurgical access port 110 together with a surgical instrument 500 willnow be described. The surgical instrument 500 may include an instrumentbody 510, a handle 520, a trigger 530, a lumen 540, and a needle tip 550located at a distal end of the surgical instrument 500. In one aspect,the surgical instrument 500 may be a percutaneous surgical instrumentthat is pre-packaged and installed with the surgical access port 110,with the lumen 540 inserted therethrough, and the surgical access port110 may be snapped in place and operatively attached to the handle 520.Alternatively, the surgical access port 110 may be provided separatelyand placed onto the lumen 540 of the surgical instrument 500 by the userprior to inserting a distal end of the lumen 540, including the needletip 550, of the instrument 500 into the patient's fascia, body wall,and/or body cavity. In one aspect, the lumen 540 and needle tip 550 maybe in the form of the needle lumen 400 shown in FIGS. 14 and 15 , andmay be interchangeably attached to the handle 520. In one aspect, thesurgical access port 110 may be attached to the surgical instrument 500as shown in FIG. 15 .

Next, as shown in FIGS. 17 and 19 , the needle tip 550 of the surgicalinstrument 500 may be used to penetrate through a body wall 1000 of thepatient, piercing a hole 1010 through the body wall 1000. In one aspect,the body wall 1000 may be a part of the abdominal wall of the patient. Alength of the lumen 540 of the surgical instrument 500 may be insertedinto a body cavity 1020 defined at least in part by the body wall 1000of the patient. Once a length of the lumen 540 has been inserted intothe body cavity, the surgical access port may be mounted to the bodywall 1000 in order for other operative instruments to be later insertedinto the same position, as will be described in further detail below.

In one aspect, once the lumen 540 has been inserted into the body cavity1020, the surgical access port 110 may be slid down and advanced overthe lumen 540, in a distal direction, towards the body cavity 1020, asshown in FIG. 19 . The elongated cannula 115 of the surgical access port110 may then be inserted through the hole 1010 generally created by theneedle tip 550 and lumen 540 of the surgical instrument 500, asdiscussed above. In the process, the elongated cannula 115 may widen thehole 1010 created by the needle tip 550 and lumen 540.

The surgical access port 110 may then be further secured to the patientusing the locking mechanism 300. The locking mechanism 300 may bepre-packaged and installed on the surgical instrument 500 together withthe surgical access port 110. Alternatively, prior to the surgicalinstrument 500 being inserted into the patient, the locking mechanism300 may be advanced over the lumen 540 of the surgical instrument, in aproximal direction. The locking mechanism 300 may then be furtheradvanced over the elongated cannula 115 and locked to the surgicalaccess port 110 by squeezing or pinching tabs 312A and 322A of thelocking mechanism 300 together to place the device in a locked position.After the elongated cannula 115 of the surgical access port 110 has beeninserted through the hole 1010, the adhesive portion of the base 310 maybe secured onto the patient's fascia to secure the surgical access port110 in place.

Referring to FIG. 18 , in one aspect, the surgical instrument 500 may beoperated within the body cavity 1020 prior to the surgical access port110 being inserted into the hole 1010. For example, the surgicalinstrument 500 may include a pair of graspers 560 which may be used toperform a grasping function within the body cavity 1020 prior to and/orafter the surgical access port 110 has been inserted into the hole 1010.

Referring to FIG. 19 , once the surgical instrument 500 is no longerneeded, the surgical access port 110 may be left in the body cavity1020. In one aspect, the cap 150 (shown in FIG. 7 ) may be attached tothe hub of the surgical access port 110 in order to seal the taperedopen end portion 126 of the hub 120. When the surgical instrument 500 orother instruments need to be inserted into the body cavity 1020, the cap150 may be removed and the surgical instrument 500 or other instrumentsmay be inserted through the surgical access port 110. As will beappreciated by one skilled in the art in view of the present disclosure,a number of different instruments may access the body cavity 1020 viathe surgical access port 110 throughout a surgery. Once the surgery iscomplete the surgical access port 110 may be removed manually by pullingthe surgical access port 110 away from the body cavity 1020, or thesurgical access port 110 may be slid back up the last instrument's shaftor lumen, snapped onto the back of said instrument's shaft and/or handleusing the at least inner rings 118A, 118B, 118C of the surgical accessport 110, and removed from the patient's body cavity, back through thebody wall 1000 and out of the patient's fascia.

In one aspect, the surgical access port assembly 100 may be used afterthe surgeon has inserted an endoscope with a camera into a body cavity1000, wherein the cavity 1000 may be subject to insufflation and/ordistended. Using the endoscope and camera, the surgeon would locate apart of the patient's fascia for insertion of the surgical access port110. The tip 130 of the surgical access port 110 may be removed toreveal the sharp tip 250 of the obturator 200. The surgeon would eithercreate a small incision in the patient's fascia or use sufficient forceto insert the surgical access port 110 via the sharp tip 250 at thedistal end of the obturator 200. Once the surgical access port 110 hasbeen inserted into the body cavity 1020, the obturator 200 may beremoved. Either during the insertion step or after, the surgeon canadjust the angle of the surgical access port 110 via movement of thelocking mechanism 300, more specifically via the movements of the ball330. The locking mechanism 300 may be locked and also adhered to thepatient's fascia via the adhesive on the lower portion of the base 310,with the surgeon removing the paper liner 340 via the tab 345. Onceinserted, the distal end of the surgical access port 110 will be withinthe body cavity 1020 while the proximal end of the cannula 115 and thehub 120 extend out of the patient's fascia. The body cavity 1020 istherefore accessible for various surgical instruments.

Further advantages of the surgical access port assembly 100 of thepresent disclosure include retention of abdominal pressure during anabdominal surgery. Also the inventive device when in use during asurgery may be self-sealing without compromising insufflation pressure.While not being bound by theory, the inventors of the presentapplication believe that dynamic friction between the outer edge of thesmall diameter cannula 115 and the patient's fascia and body wall resultin minimal gas leakage during insufflation. Furthermore, in one aspect,control of an entry depth of the surgical access port 110 may bepossible through retention and/or pivot of the locking mechanism 300.Thus, in use, the surgical access port assembly 100 of the presentdisclosure may enable a smaller diameter incision point, better angleand control for surgical instrument access into the body cavity, whilestill maintaining sufficient insufflation. The absence of a valve andsealing mechanism may result in lower friction which in turn may improveprecision during the surgery. Such improved precision also reduces thesurgical time and duration of the surgery which in turn improvessurgical recovery by the patient and may reduce surgical complicationsand scarring.

Unlike typical trocars, the surgical access port 110 may be attached tothe back end of the percutaneous instrument and may be slid down theshaft of the instrument into the patient's body to provide re-access tothe same site location if the percutaneous instrument were to be removedor exchanged. While trocars are independently inserted in to the bodycavity, the surgical access port 110 differs from typical trocars inthat the surgical access port 110 may be slid into the body cavity overan instrument pre inserted into the body cavity.

In one aspect, the surgical access port 110 and the surgical instrument500 may be packaged as a kit, whereby the surgical access port 110 isplaced onto and snapped onto the lumen of the surgical instrument 500.It is also envisioned where the surgical access port 110 would bepackaged separately, as a stand-alone product and may be attached to thesurgical instrument 500 as needed.

The system and methods associated with the surgical access port includesimproved surgical precision, reduced surgical time resulting in reducedtrauma to the patient and possibly less scarring, reduced recovery time,less pain, easier handling of the device by the user via the lockedrotational hub and multiple types of end-effectors, and other benefits.

It will be appreciated that the foregoing description provides examplesof the surgical access port which may be used with a surgical instrumentfor minimally invasive surgery. However, it is contemplated that otherimplementations of the disclosure may differ in detail from theforegoing examples. All references to the disclosure or examples thereofare intended to reference the particular example being discussed at thatpoint and are not intended to imply any limitation as to the scope ofthe disclosure more generally. All language of distinction anddisparagement with respect to certain features is intended to indicate alack of preference for those features, but not to exclude such from thescope of the disclosure entirely unless otherwise indicated.

Recitation of ranges of values herein are merely intended to serve as ashorthand method of referring individually to each separate valuefalling within the range, unless otherwise indicated herein, and eachseparate value is incorporated into the specification as if it wereindividually recited herein. All methods described herein can beperformed in any suitable order unless otherwise indicated herein orotherwise clearly contradicted by context.

The invention claimed is:
 1. A locking mechanism for a surgical accessport, the locking mechanism comprising: a lock base having a tab and anaperture configured to receive the surgical access port; and a lockingmember having a lock tab and an opening configured to receive thesurgical access port, wherein the locking member is configured to rotaterelative to the lock base into a locked position to secure the surgicalaccess port when inserted into fascia, and wherein the locking member isconfigured to rotate relative to the lock base into an unlocked positionwhen the tab and the lock tab are squeezed together.
 2. The lockingmechanism of claim 1, further comprising an adhesive on the lock base tosecure the lock base to the fascia.
 3. The locking mechanism of claim 1,further comprising a ball configured to fix a rotational orientation ofthe surgical access port in the locked position.
 4. The lockingmechanism of claim 3, wherein the ball has an opening configured toreceive the surgical access port.
 5. The locking mechanism of claim 3,wherein the ball is received between the lock base and the lockingmember.
 6. The locking mechanism of claim 5, wherein the locking memberis configured to compress the ball in the locked position.
 7. Thelocking mechanism of claim 6, wherein the ball includes at least oneslit that is compressed in the locked position.
 8. The locking mechanismof claim 3, wherein the lock base has a frustoconical inner surface atleast partially supporting the ball.
 9. The locking mechanism of claim1, wherein the lock base comprises a central ring defining at least onescrew thread or ramp, and the locking member comprises at least one snapor finger received in the at least one screw thread or ramp to enablerelative rotation.
 10. A surgical access port assembly comprising: asurgical access port; and a locking mechanism comprising: a lock basehaving a tab and an aperture configured to receive the surgical accessport; and a locking member having a lock tab and an opening configuredto receive the surgical access port, wherein the locking member isconfigured to rotate relative to the lock base into a locked position tosecure the surgical access port when inserted into fascia, and whereinthe locking member is configured to rotate relative to the lock baseinto an unlocked position when the tab and the lock tab are squeezedtogether.
 11. The surgical access port assembly of claim 10, wherein thelocking mechanism further comprises an adhesive on the lock base tosecure the lock base to the fascia.
 12. The surgical access portassembly of claim 10, wherein the locking mechanism further comprises aball configured to fix a rotational orientation of the surgical accessport in the locked position.
 13. The surgical access port assembly ofclaim 12, wherein the ball has an opening configured to receive thesurgical access port.
 14. The surgical access port assembly of claim 12,wherein the ball is received between the lock base and the lockingmember.
 15. The surgical access port assembly of claim 14, wherein thelocking member is configured to compress the ball in the lockedposition.
 16. The surgical access port assembly of claim 15, wherein theball includes at least one slit that is compressed in the lockedposition.
 17. The surgical access port assembly of claim 12, wherein thelock base has a frustoconical inner surface at least partiallysupporting the ball.
 18. The surgical access port assembly of claim 12,wherein the lock base comprises a central ring defining at least onescrew thread or ramp, and the locking member comprises at least one snapor finger received in the at least one screw thread or ramp to enablerelative rotation.
 19. A method of securing a surgical access port tofascia with a locking mechanism having a lock base and a locking member,the method comprising: receiving the surgical access port in an apertureof the lock base and an opening of the locking member, inserting thesurgical access port into the fascia; and rotating the locking memberrelative to the lock base into a locked position to secure the surgicalaccess port; and rotating the locking member relative to the lock baseinto an unlocked position by squeezing together a tab of the lock baseand a lock tab of the locking member to remove the surgical access portonce surgery is complete.